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Claims for Patent: 7,622,470

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Claims for Patent: 7,622,470

Title:Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Abstract:T cell lymphoma is treated by administering to a patient suffering from T cell lymphoma a therapeutically effective amount of 10-propargyl-10-deazaaminopterin. Remission is observed in human patients, even with drug resistant T cell lymphoma at weekly dosages levels as low as 30 mg/m.sup.2. In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.
Inventor(s): O'Connor; Owen A. (Scarsdale, NY), Sirotnak; Francis M. (Hampton Bays, NY)
Assignee: Sloan-Kettering Institute for Cancer Research (New York, NY)
Application Number:11/141,868
Patent Claims: 1. A method for treatment of peripheral T cell lymphoma excluding mycosis fungoides comprising administering to a human having a peripheral T cell lymphoma other than mycosis fungoides a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin.

2. A method for treatment of peripheral T cell lymphoma excluding mycosis fungoides comprising administering to a human having a peripheral T cell lymphoma other than mycosis fungoides a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

3. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

4. The method of claim 3, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

5. The method of claim 4, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

6. The method of claim 4, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

7. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

8. The method of claim 7, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

9. The method of claim 2, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

10. The method of claim 2, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

11. The method of claim 10, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

12. The method of claim 10, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

13. The method of claim 2, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

14. The method of claim 13, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

15. The method of claim 1, wherein the peripheral T cell lymphoma is an a Human T-lymphotropic virus (HTLV) Associated T-cell Lymphoma/leukemia.

16. The method of claim 15, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

17. The method of claim 16, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

18. The method of claim 16, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

19. The method of claim 18, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

20. The method of claim 18, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

21. The method of claim 16, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

22. The method of claim 21, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

23. The method of claim 1, wherein the peripheral T cell lymphoma is a subcutaneous Panniculitic T-cell Lymphoma.

24. The method of claim 23, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

25. The method of claim 24, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

26. The method of claim 24, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

27. The method of claim 26, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

28. The method of claim 26, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

29. The method of claim 24, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

30. The method of claim 29, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount from 135 to 275 mg/m.sup.2 per dose.

31. The method of claim 1, wherein the peripheral T cell lymphoma is selected from: T cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; aggressive NK-cell leukemia; cutaneous T cell lymphoma excluding mycosis fungoides; anaplastic large cell lymphoma, T cell type; enteropathy-type T cell lymphoma; Adult T-cell leukemia/lymphoma; angioimmunoblastic T cell lymphoma; subcutaneous panniculitic T cell lymphoma; and peripheral T cell lymphomas that initially involve a lymph node paracortex and never grow into a true follicular pattern.

32. The method of claim 31, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

33. The method of claim 32, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

34. The method of claim 32, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

35. The method of claim 34, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

36. The method of claim 34, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

37. The method of claim 32, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

38. The method of claim 37, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

39. The method of claim 1, wherein the human treated has relapsed or refractory peripheral T cell lymphoma.

40. The method of claim 39, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

41. The method of claim 39, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

42. The method of claim 41, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

43. The method of claim 41, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

44. The method of claim 39, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

45. The method of claim 44, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

46. The method of claim 39, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

47. The method of claim 46, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

48. The method of claim 39, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

49. The method of claim 48, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

50. The method of claim 48, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

51. The method of claim 50, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

52. The method of claim 50, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

53. The method of claim 48, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

54. The method of claim 53, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

55. The method of claim 2, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

56. The method of claim 55, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

57. The method of claim 32, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

58. The method of claim 57, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

59. The method of claim 48, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

60. The method of claim 59, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

61. The method of claim 55, further comprising supplementation with folic acid and vitamin B.sub.12.

62. The method of claim 57, further comprising supplementation with folic acid and vitamin B.sub.12.

63. The method of claim 59, further comprising supplementation with folic acid and vitamin B.sub.12.

64. The method of claim 31, wherein the peripheral T cell lymphoma is Sezary syndrome.

65. The method of claim 31, wherein the peripheral T cell lymphoma is Adult T cell leukemia/lymphoma associated with Human T-lymphotropic virus-1 (HTLV-1).

66. The method of claim 31, wherein the composition is administered as an oral liquid or as an injectable solution.

67. The method of claim 1, wherein the composition is administered as an oral liquid or as an injectable solution.

68. The method of claim 2, wherein the composition is administered as an oral liquid or as an injectable solution.

69. A method for treatment of peripheral T cell lymphoma excluding mycosis fungoides comprising administering to a human having a peripheral T cell lymphoma other than mycosis fungoides a composition comprising a therapeutically effective amount of a salt form of 10-propargyl- 10-deazaaminopterin.

70. The method of claim 69, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

71. The method of claim 69, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

72. The method of claim 71, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

73. The method of claim 71, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

74. The method of claim 69, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

75. The method of claim 74, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

76. The method of claim 69, wherein the peripheral T cell lymphoma is a Human T-lymphotropic virus (HTLV) Associated T-cell Lymphoma/leukemia.

77. The method of claim 76, wherein the composition is administered as an oral liquid or injectable solution.

78. The method of claim 76, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

79. The method of claim 76, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

80. The method of claim 79, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

81. The method of claim 79, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

82. The method of claim 76, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

83. The method of claim 82, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

84. The method of claim 69, wherein the peripheral T cell lymphoma is a subcutaneous Panniculitic T-cell Lymphoma.

85. The method of claim 84, wherein the composition is administered an oral liquid or as an injectable solution.

86. The method of claim 84, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

87. The method of claim 84, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

88. The method of claim 86, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

89. The method of claim 86, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

90. The method of claim 84, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

91. The method of claim 90, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount from 135 to 275 mg/m.sup.2 per dose.

92. The method of claim 69, wherein the peripheral T cell lymphoma is selected from: T cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; aggressive NK-cell leukemia; cutaneous T cell lymphoma excluding mycosis fungoides; anaplastic large cell lymphoma, T cell type; enteropathy-type T cell lymphoma; Adult T-cell leukemia/lymphoma; angioimmunoblastic T cell lymphoma; subcutaneous panniculitic T cell lymphoma; and peripheral T cell lymphomas that initially involve a lymph node paracortex and never grow into a true follicular pattern.

93. The method of claim 92, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

94. The method of claim 92, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

95. The method of claim 94, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

96. The method of claim 94, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

97. The method of claim 92, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

98. The method of claim 97, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

99. The method of claim 92, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

100. The method of claim 99, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

101. The method of claim 100, further comprising supplementation with folic acid and vitamin B.sub.12.

102. The method of claim 69, wherein the human treated has relapsed or refractory peripheral T cell lymphoma.

103. The method of claim 102, wherein the composition is administered as an injectable solution.

104. The method of claim 102, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

105. The method of claim 102, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

106. The method of claim 95, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

107. The method of claim 95, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

108. The method of claim 102, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

109. The method of claim 108, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

110. The method of claim 102, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

111. The method of claim 110, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

112. The method of claim 69, wherein the peripheral T cell lymphoma is Sezary syndrome.

113. A method for treatment of peripheral T cell lymphoma excluding mycosis fungoides comprising administering to a human having a peripheral T cell lymphoma other than mycosis fungoides a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin in salt form substantially free of 10-deazaaminopterin.

114. The method of claim 113, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

115. The method of claim 113, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

116. The method of claim 115, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

117. The method of claim 115, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

118. The method of claim 113, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

119. The method of claim 118, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

120. The method of claim 113, wherein the composition is administered as an oral liquid or as an injectable solution.

121. The method of claim 113, wherein the peripheral T cell lymphoma is a Human T-lymphotropic virus (HTLV) Associated T-cell Lymphoma/leukemia.

122. The method of claim 121, wherein the composition is administered as an oral liquid or injectable solution.

123. The method of claim 121, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

124. The method of claim 121, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

125. The method of claim 124, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

126. The method of claim 124, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

127. The method of claim 121, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

128. The method of claim 126, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

129. The method of claim 113, wherein the peripheral T cell lymphoma is a subcutaneous Panniculitic T-cell Lymphoma.

130. The method of claim 129, wherein the composition is administered an oral liquid or as an injectable solution.

131. The method of claim 129, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

132. The method of claim 131, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

133. The method of claim 132, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

134. The method of claim 132, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

135. The method of claim 131, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

136. The method of claim 135, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount from 135 to 275 mg/m.sup.2 per dose.

137. The method of claim 113, wherein the peripheral T cell lymphoma is selected from: T cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; aggressive NK-cell leukemia; cutaneous T cell lymphoma excluding mycosis fungoides; anaplastic large cell lymphoma, T cell type; enteropathy-type T cell lymphoma; Adult T-cell leukemia/lymphoma; angioimmunoblastic T cell lymphoma; subcutaneous panniculitic T cell lymphoma; and peripheral T cell lymphomas that initially involve a lymph node paracortex and never grow into a true follicular pattern.

138. The method of claim 137, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

139. The method of claim 137, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

140. The method of claim 139, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

141. The method of claim 139, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

142. The method of claim 137, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

143. The method of claim 142, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

144. The method of claim 137, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

145. The method of claim 144, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

146. The method of claim 137, further comprising supplementation with folic acid and vitamin B.sub.12.

147. The method of claim 113, wherein the human treated has relapsed or refractory peripheral T cell lymphoma.

148. The method of claim 147, wherein the composition is administered as an injectable solution.

149. The method of claim 147, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

150. The method of claim 147, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

151. The method of claim 150, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

152. The method of claim 150, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

153. The method of claim 147, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

154. The method of claim 153, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 135 to 275 mg/m.sup.2 per dose.

155. The method of claim 147, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

156. The method of claim 155, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

157. The method of claim 113, wherein the peripheral T cell lymphoma is Sezary syndrome.

158. The method of claim 113, wherein the peripheral T cell lymphoma is Adult T cell leukemia/lymphoma associated with Human T-lymphotropic virus-1 (HTLV-1).

159. The method of claim 113, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

160. The method of claim 159, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

161. The method of claim 113, further comprising supplementation with folic acid and vitamin B.sub.12.
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